Brought to you by Thermo Fisher Scientific.

Wednesday, January 17, 2024, 8am – 9am. (Breakfast included)

A key factor that promotes positive clinical outcomes in cell therapy manufacturing is the achievement of a younger, less differentiated T cell population at the outset of the manufacturing process. In this talk, you will hear about new flexible solutions that increase control over target cell isolation and activation steps upstream in the process while simultaneously providing process flexibility for steps downstream. These new tools are designed to incorporate into a closed, scalable and automatable workflow, helping to streamline the process, with the potential to greatly reduce manufacturing timelines. This suite of modular instruments and tools spans the end-to-end workflow allowing the user greater flexibility and control of their process parameters to modulate the nuanced variables that affect end-point therapeutic efficacy.

Register your place via the form at the bottom of the page.

Brought to you by Invetech.

Wednesday, January 17, 2024, 8am – 9am. (Breakfast included)

Successfully automating a cell therapy manufacturing program requires flexibility, process understanding, and collaboration to push boundaries and unlock new possibilities. This panel will explore considerations for transitioning to automated systems, developing a roadmap to implementation and how collaborative partnerships can assist in navigating this path, streamlining cell therapy process development and manufacturing.
In this session we’ll discuss:
– Driving factors for transitioning to automated systems at different stages of the development journey. What do manufacturing expectations look like and how do they change from clinical development to commercial scale?
– The transformative potential of configurable, modular, and customizable solutions that cater to the unique requirements of cell therapy production.
– The need for flexible and adaptable platforms that can scale and the importance of thinking about this early in the process.
– Benefits of partnerships and their positive impact on accelerating the pace of cell therapy manufacturing development by rethinking how to overcome obstacles and design a robust process.
Join us for an engaging discussion highlighting innovation-driven partnerships’ crucial role in bridging the gap between current practices and future advancements in cell therapy manufacturing.

Register your place via the form at the bottom of the page.

Brought to you by Merit.

Wednesday, January 17, 2024, 11am – 12pm. (Brunch included)

• How design led, technology driven, offsite construction can deliver a biotech facility faster than traditional build construction methods
• What funding solutions are available to deliver a new building to avoid capital cost expenditure
• Delivering an environmentally friendly and sustainable building where scope 1 carbon emissions are eliminated

Register your place via the form at the bottom of the page.

Brought to you by Cytiva.

Wednesday, January 17, 2024, 2pm – 3pm. (Lunch included)

Allogeneic cell therapies represent a new modality that will allow more patients to be treated using healthy donor-derived cells. However, even as the field begins to show success in clinical trials and beyond, critical bottlenecks related to chemistry, manufacturing, and controls (CMC) pose challenges for bringing these therapies to patients on a global scale. From a joint vision and combining complementary strengths, Bayer and Cytiva have teamed up to develop and deliver solutions for producing allogeneic cell therapies at the scale and quality required by the industry.

Register your place via the form at the bottom of the page.

Brought to you by ScaleReady.

Thursday, January 18, 2023, 8am – 9am. (Breakfast included)

Audience Learnings:

• Comprehensive Insight into CAR-T Cell Production: Participants can expect to gain a nuanced understanding of the intricacies involved in CAR-T cell manufacturing, including the technological and procedural complexities, and the obstacles that currently impede streamlined production.
• Integration of Broader Manufacturing Principles: Audience members will learn how principles from other manufacturing sectors, such as the automotive industry’s lean manufacturing, can be applied to the production of CAR-T cells to improve efficiency and product consistency and why G-Rex is a perfect manufacturing device to enhance this model.
• Recognition of Successful Cross-Industry Applications: Attendees will be exposed to real-world examples where cross-industry innovations have been adopted in the CAR-T cell manufacturing biomedical field. They will learn about the potential for such crossover techniques to be utilized in CAR-T cell production, fostering a mindset open to interdisciplinary solutions.
• Understanding Regulatory Compliance in Innovation: The presentation will provide attendees with a clear distinction between the myths and facts of regulatory compliance when implementing new manufacturing practices in cell therapy. They will learn strategies for ensuring safety, efficacy, and adherence to FDA standards while embracing new methods for increased throughput, capacity, and efficiency.

Register your place via the form at the bottom of the page.

Brought to you by FUJIFILM Irvine Scientific.

Thursday, January 18, 2023, 8am – 9am. (Breakfast included)

• Are you looking to speed up and scale out your cell therapy outcomes?
• Do you have media development challenges that need to be improved?

In recent years, there has been a significant increase in Advanced Cell Therapies (ACT), which have the potential to transform the treatment of a number of diseases, such as cancer, genetic conditions, and degenerative diseases.

For the purposes of this panel review, we approaching these developments- and production-related challenges from a cell culture media perspective and highlighting its importance as a critical ancillary material throughout the development, manufacturing, and scale-up of ACTs.

Making the right decision the first time on in the process can help to save valuable time, money, and resources, especially when transitioning into the clinical trial phase and further scale-up.

Join us and our panel of experts as we discuss the challenges cell therapy developers have and solutions that can help speed time to market and remove bottlenecks before they happen.

Register your place via the form at the bottom of the page.

Brought to you by Miltenyi.

Thursday, January 18, 2024, 2pm – 3pm. (Lunch included)

In a more cautious economic landscape, it is more critical than ever to demonstrate a thorough and realistic plan to commercialization. This has to be balanced with the pressure to move quickly in an increasingly competitive space.

Join us for an interactive simulation, where you’ll work with your team to bring your asset to market:

Growing through all stages of clinical development, you’ll have to make choices around developing your process, whether to outsource, when to defer costs, how and when to build out capacity, and more.

Under real-world budget and time constraints, you’ll develop and execute your operating strategy, secure funding, and make tough trade-offs as you race other teams to be the first to market.

Come and enjoy some good food, meet new people, and engage in friendly competition and thought-provoking discussion.

And yes, there will be prizes.

Register your place via the form at the bottom of the page.

Brought to you by Resilience.

Thursday, January 18, 2024, 2pm – 3pm. (Lunch included)

Analytical development remains a critical component of the advanced therapies landscape, but lengthy production timelines and inherent complexity mean that improving analytical processes and expediting release times remain a key priority. With a variety of starting materials, manufacturing processes and assay technologies, how does one balance the need for deep biological insights without sacrificing precious turnaround times and commercially sustainable cost? Is there a method that can satisfy these 3 requirements for advanced therapy success?

Join us as we take a deep dive into the critical components of analytical development strategy, method development and innovative technologies that Resilience is developing aimed at optimizing release testing, meeting regulatory requirements, and impacting COGS. Our panel will share insights and innovations from our cutting-edge R&D team paving the way for advanced therapy analytics.

Register your place via the form at the bottom of the page.

The Germfree Mobile Cleanroom Experience is back for its second year at Advanced Therapies Week following its launch of the bioGO® cGMP Mobile Cleanroom at the event in 2022.

The ongoing critical constraints confronting new and emerging advanced therapies prompted the development of this mobile unit to assist in addressing industry-wide constraints. As new technologies emerge in the biopharmaceuticals industry and the industry evolves, it is critical that manufacturing, development, and delivery processes keep up in order to deliver these therapies to patients, emphasizing the importance of decentralized models.

Germfree’s bioGO Mobile cGMP Cleanrooms are the ideal solution as they deliver a fast, adaptive, and cost-effective solution to address the needs of their clients and patients.

The Germfree truck is located inside the main exhibition hall towards to the back near the super planary.

You can download the floor plan here

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Address: (6 minute drive from the conference center)

4441 Collins Avenue Miami Beach Florida 33140

This hotel will be the central hub for everything Advanced Therapies Week, away from the Convention Center. You’ll be just a few steps away from morning yoga, the Advanced Therapies Awards, the famous Yacht Party, and the fun run. You never know who you might bump into in the hotel lobby or bar –  we know this is how some of the best connections are made!

Click here to book.

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Address: (5 minute drive from the conference center)

4041 Collins Avenue Miami Beach Florida 33140

A short 5 minute walk from our headquarter hotel, the Fontainebleau – the location of all our networking events.

Please note this hotel is now sold out.